A Novel Neurorehabilitation Approach for Cognitive Aging With HIV (HtDCS)
2017年5月12日 更新者:Pariya L. Fazeli, PhD、University of Alabama at Birmingham
Speed of Processing Training With Transcranial Direct Current Stimulation in Older HIV+ Adults (HtDCS)
The goal of this study is to conduct a small, self-contained project to test the hypothesis that tDCS will augment SOP cognitive remediation therapy (CRT) in older HIV+ adults.
The investigators will randomly assign 60 HIV+ older adults (i.e., ≥ 50 years old) to 10-hours in either a SOP CRT + sham tDCS condition (n=30) or SOP CRT + active tDCS condition (n=30) and examine neurocognitive functioning at baseline and 6 weeks post-intervention.
Hypothesis 1: The SOP CRT + active tDCS condition will show larger proximal (i.e., SOP) gains than the SOP CRT + sham tDCS condition.
Hypothesis 2: The active tDCS condition will demonstrate generalization to secondary neurocognitive domains compared to the sham tDCS condition.
研究概览
研究类型
介入性
注册 (实际的)
42
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- UAB 1917 Clinic
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- HIV+
- Aged 50 and older
- Patient at University HIV/AIDS Clinic
Exclusion Criteria:
- Not homeless
- Not blind or deaf
- No significant neuromedical issues (e.g., schizophrenia, bipolar disorder, stroke, epilepsy or history of seizures)
- No pacemaker or other biomedical devices or metal implants
- No untreated hypertension
- Not undergoing chemo or radiation
- No head injury with LOC greater than 30 mins
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Sham tDCS + Cognitive Remediation
Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off).
Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.
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tDCS is a low level electrical stimulation that will be applied to F10.
The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes.
Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.
其他名称:
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实验性的:Active tDCS + Cognitive Remediation
Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off).
Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.
|
tDCS is a low level electrical stimulation that will be applied to F10.
The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes.
Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in the Processing of Speed
大体时间:baseline, 6 week posttest
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Computerized and paper & pencil processing speed measures were used to evaluate this outcome.
The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures.
Specifically, they assess perceptual speed.
In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments.
The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set.
Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments.
Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit.
For each measure, the total score is the number of correct answers from all three sets.
Larger scores indicate better reasoning and cognitive functioning.
In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score.
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baseline, 6 week posttest
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Driving Simulator Performance
大体时间:baseline, 6 week posttest
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Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive).
A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition).
A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change.
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baseline, 6 week posttest
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Pariya L Fazeli, PhD、University of Alabama at Birmingham
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年3月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2015年3月5日
首先提交符合 QC 标准的
2015年3月12日
首次发布 (估计)
2015年3月18日
研究记录更新
最后更新发布 (实际的)
2017年5月15日
上次提交的符合 QC 标准的更新
2017年5月12日
最后验证
2017年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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